BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 10343840 · Received July 30, 2020

    Report

    Report Number
    8010047-2020-05027
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 9, 2020
    Report Date
    November 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED AND A DEVICE EVALUATION COMPLETED FOR IT. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. THE DEVICE HISTORY RECORD REVIEW FOR THE LOT INDICATED NO ANOMALY WITH THE INSPECTION. THE ACTUAL LOT # ON THE DEVICE IS KR911729 AND KR912106 IS THE PACKAGE LOT #. THE REPORTED ISSUE OF THE DEVICE WAS THE TEFLON PAD MELTED. THE DEVICE WAS ATTACHED TO THE USG-400/ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE PASSED THE PROBE CHECK. BOTH SWITCHES WERE CHECKED AND FOUND BOTH SWITCHES ARE FUNCTIONAL. A VISUAL INSPECTION ON THE RECEIVED CONDITION WAS PERFORMED ON THE DEVICE; THERE IS SOME TISSUE BUILD UP. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND IT IS CHARRED AND PARTIALLY MISSING, EXPOSING METAL; MISSING PORTION NOT RETURNED. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE, AND SOME CHARRING AND TISSUE BUILDUP WAS FOUND, CONSISTENT WITH USE. THE WIPER MOVEMENT IS NORMAL. THE CONSISTENCY OF MOVEMENT OF THE HANDLE AND JAW IS NORMAL. THE HANDLE LOAD IS NORMAL. THE ROTATION OF THE KNOB TORQUE IS NORMAL AND SMOOTH. THE PROBE AND GRASPING SECTION COATING WAS PARTIALLY PEELING. THE EXACT CAUSE OF THE EVENT CANNOT BE EXCLUSIVELY IDENTIFIED. FROM THE PAST INVESTIGATION RESULTS, THE INTENSIVELY WORN OF THE TISSUE PAD IS LIKELY TO HAVE OCCURRED IN THE FOLLOWING MANNER: ¿ ¿SEAL & CUT¿ OUTPUT WAS ACTIVATED WHILE GRASPING NOTHING WITH THE GRASPING SECTION AND THE PROBE TIP, OR KEPT ACTIVATING THE OUTPUT AFTER A TRANSECTION OF TISSUE. PEEL-OFF OF THE PROBE COATING MAY HAVE HAPPENED THUS: ¿ ACTIVATE THE DEVICE IN SEAL AND CUT MODE FOR A LONG DURATION WHILE NO TISSUE IS GRASPED BY THE GRASPING SECTION AND THE DISTAL END OF THE PROBE. ACTIVATION IN SEAL & CUT MODE CONTINUED AFTER COMPLETION OF A TISSUE CUTTING IS ALSO INCLUDED IN SUCH ACTIVATION. THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING STATEMENTS: ·DO NOT ACTIVATE OUTPUT IN SEAL & CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL, OR ENSURING THAT TISSUE IS TRANSECTED. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE DUE TO A FRICTION BETWEEN THE PROBE TIP AND THE GRASPING SECTION MAY RESULT IN VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE TISSUE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING. ¿ WHEN CUTTING AND VESSEL SEALING IS PERFORMED IN SEAL & CUT MODE, APPLY LIGHT TENSION ON THE TISSUE SO THAT USERS CAN CONFIRM IT IS TRANSECTED. ALSO, STOP ACTIVATION IMMEDIATELY AFTER TISSUE IS TRANSECTED. OTHERWISE, THE GRASPING SECTION, THE TISSUE PAD, OR THE PROBE TIP MAY BREAK AND FALL OFF, AND PARTIAL SEPARATING OF THE TISSUE PAD MAY OCCUR DUE TO A LOCAL INCREASE OF TEMPERATURE CAUSED BY THE FRICTION BETWEEN TISSUE PAD AND THE PROBE TIP DURING ACTIVATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE, THE TISSUE PADS OF BOTH HANDLES OF THE DEVICE MELTED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR HARM OCCURRED. IT WAS NOTED THE DEVICE WAS INSPECTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812031 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR911729 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1 6 WK TB-0535FCS SERIAL (B)(6)| TD-TB400 SERIAL UNKNOWN| TB-0535FCS SERIAL KR910812| TD-TB400 SERIAL UNKNOWN